POS0706 LONG-TERM HYDROXYCHLOROQUINE TREATMENT IMPROVES ESSPRI AND ESSDAI IN PATIENTS WITH PRIMARY SJOGREN’S SYNDROME
Authors: N. Hashimoto, T. Nakazawa, T. Iwasaki, T. Hashimoto
Journal: Annals of the Rheumatic Diseases (2022)

Background Primary Sjögren’s syndrome (pSS) is a chronic, systemic autoimmune disease typically affecting the salivary and lacrimal glands and producing symptoms of dry mouth, dry eyes, fatigue and pain. Hydroxychloroquine (HCQ) have been shown to have various immunomodulatory and immunosuppressive effects, and currently have established roles in the management of rheumatoid arthritis and systemic lupus erythematosus (SLE). However, the use of HCQ in pSS is based in expert recommendations and in few studies with a low level of evidence. There are very few publications assessing HCQ use in a double-blind, randomized, and placebo-controlled studies. In Japan, HCQ is indicated for patients with SLE and cutaneous lupus erythematosus (CLE) and is off-label use for pSS patients without CLE. Recently, ESSPRI and ESSDAI have been developed by the European League Against Rheumatism (EULAR) SS study group as standardized outcome tools for measuring patients’ reported symptoms and disease-specific activity. ESSDAI and ESSPRI have been proven to be valid and reliable, they have been used to select patients or as the primary or secondary outcome measures in clinical trials. Objectives The aim of this study was to examine the efficacy of HCQ in pSS at 8 and 52 weeks after treatment evaluated by ESSPRI and ESSDAI. Methods Twenty-six pSS patients (26 female, mean age 51.6 ± 13.6 years) with CLE who fulfilled the ACR/EULAR classification criteria for SS and/or the Japanese Ministry of Health and Welfare criteria for SS were studied. The clinical indexes were evaluated by ESSDAI, ESSPRI, IgG and CH50 before and after HCQ treatment at 8 and 52weeks. ESSPRI components were calculated individually and as a single factor composed of the mean of the three components (pain, fatigue, and dryness: VAS 0-10). ESSDAI (0–123) proposes the evaluation of 12 domains or organ systems (constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, peripheral nervous system, central nervous system, muscular, hematological and biology). Results ESSPRI and component of fatigue and pain were significantly lower at 8 and 52 weeks after treatment than HCQ pre-treatment (ESSPRI: 4.14±1.45 vs 3.38±1.57, 3.34±1.56, p=0.005, p=0.045, fatigue: 4.68±2.12 vs 3.68±1.96, 3.58±1.87, p=0.010, p=0.036, pain: 3.32±1.94 vs 2.09±1.60, 1.79±1.51, p=0.0043, p=0.0014). However, there was no significant difference in dryness component between HCQ pre-treatment and 8 and 52 weeks after treatment (4.41 ± 2.09 vs 4.32 ± 2.06, 4.21 ± 2.39, p = 0.71, p = 0.94), and the amount of saliva produced by the gum test also showed no significant difference between pre-HCQ treatment and 52 weeks after treatment (8.21 ± 6.72 vs 8.24 ± 6.79 mL / 10 minutes, p = 0.45). There was also a significant decrease in ESSDAI and constitutional, articular, cutaneous and biological domain at 52 weeks after treatment compared to HCQ pre-treatment (ESSDAI: 9.68±6.14 vs 4.74±6.43, p=0.0004; constitutional: 1.41±1.50 vs 0.63±1.26, p=0.034, articular: 1.00±1.02 vs 0.21±0.63, p=0.0027, cutaneous: 2.86±3.27 vs 1.11±2.49, p=0.010, biological: 1.14±0.83 vs 0.79±0.86, p=0.014). An improvement of at least 1 point or 15% in ESSPRI and at least 3 points in ESSDAI compared to HCQ pr-treatment were observed in 63.6% and 31.8% at 8 weeks and 73.7% and 68.4% at 52 weeks after treatment. In addition, IgG was significantly decreased at 52 weeks after treatment compared to HCQ pre-treatment (1934 ± 613 vs 1714 ± 564 mg / dL, p=0.0005). Conclusion HCQ treatment improved pain such as arthritis, fatigue, constitutional and cutaneous manifestations, but was not effective for salivary function and dryness. HCQ treatment was useful in improving ESSPRI and ESSDAI, and long-term treatment increased the number of effective cases from 8 weeks to 52 weeks. Disclosure of Interests None declared